AMSTERDAM — A weekly albumin infusion, in addition to standard medical treatment, significantly improves survival in patients with advanced liver cirrhosis, results from the ANSWER study show.
Albumin also reduced the number of hospitalizations and the rate of severe complications, improved ascites, and was generally well tolerated.
"There has been a long debate — with opinions ranging from skeptical to enthusiastic — about giving albumin to patients with cirrhosis, but a reliable study that could shed light on this was lacking until now," said Mauro Bernardi, MD, from the University of Bologna in Italy, who presented the late-breaking abstract here at the International Liver Congress 2017.
There is a need for treatment that can improve survival because of the poor prognosis of decompensated cirrhosis, which has a 1-year mortality rate of approximately 20%, explained Dr Bernardi. Liver transplantation is the only currently viable intervention.
All 431 participants in the investigator-initiated ANSWER study had cirrhosis and uncomplicated ascites, and all received standard medical treatment with antimineralocorticoids (at least 200 mg/day) and furosemide (at least 25 mg/day). In addition, 218 patients were randomized to receive human albumin 40 g twice a week for the first 2 weeks, and thereafter received 40 g per week.
Finding the ANSWER
Patients were followed for 18 months or until frequent refractory ascites occurred, a transjugular intrahepatic portosystemic shunt was required, or the patient underwent liver transplantation or died.
Overall survival at 18 months — the primary end point — was significantly better in the albumin group than in the standard-care group (78% vs 66%; P = .028).
There were also significant improvements in a number of secondary outcomes, including a 45% reduction in the cumulative number of days spent in the hospital, which was 19.4 days in the standard-care group (P < .0001). Rates of variceal bleeding, however, were not significantly different between groups.
Although the mechanisms behind the beneficial effect of albumin are not fully know, Dr Bernardi suggested it might be related to plasma expansion, as well as to the antioxidant and anti-inflammatory effects of albumin.
Table. Secondary Outcomes Favoring Albumin Over Standard Medical Treatment
|Outcome||Incidence Rate Ratio||P Value|
|Spontaneous bacterial peritonitis (SBP)||0.32||<.0001|
|Non-SBP bacterial infection||0.70||.0045|
|Hepatorenal syndrome, type 1||0.38||.0039|
|Hepatic encephalopathy, grades III and IV||0.48||<0.0001|
In the albumin group, two patients experienced a mild allergic reaction, which resolved. Two other patients had a severe life-threatening septic event — one of whom also had pneumonia, and the other of whom also had disseminated intravascular coagulation; however, both patients recovered.
A Clear Benefit, But At What Cost?
"The reduction in mortality observed in the albumin-treated arm of this randomized controlled study is a novel and important piece of information," said Annalisa Berzigotti, MD, PhD, from the University of Berne in Switzerland, who is a board member of the European Association for the Study of the Liver (EASL).
On the basis of these data, "weekly administration of albumin should be considered in patients with cirrhosis and ascites to prevent life-threatening complications," she explained.
"The results are exciting; the fact that albumin improves survival is crystal clear," said Frank Tacke, MD, PhD, from University Hospital Aachen in Germany, who is vice secretary of the EASL. "However, it's an expensive treatment, so cost-effectiveness analyses will be important."
Dr Bernardi reported that his team is currently performing an analysis to address the question of cost, because patients not treated with albumin spend more time in the hospital, which is expensive.
Dr Bernardi reports that he is a consultant for CSL Behring GmbH and Baxter Healthcare SA, and provides sponsored lectures for CSL Behring GmbH, PPTA Europe, Baxter Healthcare SA, Grifols SA, Gilead Sciences, and AbbVie Italia. Dr Tacke has disclosed no relevant financial relationships.
International Liver Congress (ILC) 2017: Abstract LBO-08. Presented April 22, 2017.
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Cite this: Albumin Improves Survival in Decompensated Cirrhosis - Medscape - Apr 24, 2017.